BELIMUMAB PACKAGE INSERT PDF

Belimumab has been studied in a limited number of SLE patients with renal syringe are provided at the end of the package leaflet (see Step-by-step. Learn about BENLYSTA (belimumab), an FDA-approved prescription infusion or self-injectable lupus medication to help treat your Request your FREE Info Kit. Keep in the original package until time of use to protect from light. Insert the entire Needle into the pinched area of the skin at a slight degree angle using a.

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It is unknown if treatment with belimumab is associated with increased risk for these events.

Safety and efficacy of belimumab have not been established in children or adolescents less than 18 years of age. Administration of belimumab requires an experienced clinician prepared to manage anaphylaxis and infusion-related reactions. The needle will automatically rise up into the needle guard.

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Your Name Your name is required. Live virus vaccines should generally not be administered to an immunosuppressed patient. Disclaimer The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment.

Small air bubbles, however, are expected and acceptable. The belimjmab of patients who reported serious depression or inert ideation had a history of depression or other serious psychiatric disorders and most were receiving psychoactive medications.

Hypersensitivity Reactions, Including Anaphylaxis: Because of its mechanism of action, belimumab may interfere with the response to immunizations. BENLYSTA is a sterile, preservative-free lyophilized bbelimumab for reconstitution, dilution, and intravenous infusion provided in single-use glass vials with a latex-free rubber stopper and a flip-off seal. Major Avoid use together. During animal studies, no evidence of embryotoxicity or fetal malformations were noted when monkeys were exposed to approximately 9 times based on intravenous administration and 20 times based on subcutaneous administration the maximum recommended human dose MRHD.

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For the pre-filled syringe, insert the entire needle into the pinched area of the skin at a slight degree angle using a dart-like motion. Serious infusion reactions excluding hypersensitivity reactions were reported in 0.

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Allow the vial to sit at room temperature during reconstitution, gently swirling the vial for 60 seconds every 5 minutes until the powder is dissolved. Once diluted, the infusion may be stored at 2 to 8 degrees C 36 to 46 degrees F or room temperature. Monoclonal antibodies, such as belimumab, are actively transported across the placenta during the third trimester of pregnancy and may beilmumab immune response in the in utero-exposed fetus.

Monitor all patients during and for an appropriate period of time after belimumab administration.

A “click” will be heard at the start of the injection. Major Live vaccines should not be given for 30 days before or concurrently with belimumab, as clinical safety has not been established. While keeping your hold on the syringe, slowly move your thumb back, allowing the plunger to rise up. Reference bslimumab National Institutes of Health, U.

Benlysta (belimumab) dose, indications, adverse effects, interactions from

If a dose is missed, administer as soon as possible. Push the plunger all the way down until all of the solution is injected. Belimumab binds BLyS and prevents it from binding to its receptors on B cells. Remove prefilled syringe or auto-injector from refrigerator and allow 30 minutes to reach room temperature.

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If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. A serious psychiatric event was reported in 0. A diagnosis of PML should be considered in any patient presenting with new-onset or deteriorating neurological signs and symptoms. Serious and sometimes fatal infections have been reported in clinical trials with belimumab or other immunosuppressive agents.

Belimumab has not been studied in combination with other biologic therapies including B-cell targeted therapies such as ofatumumab. The risks and benefits should also be considered prior to administering live or live-attenuated vaccines to an infant exposed to belimumab in utero.

Do not freeze and do not use if the injection has been frozen. Consider discontinuation of immunosuppressant therapy, including belimumab, in patients with confirmed PML. Dilute belimumab in 0. Limited data on use of belimumab during human pregnancy, either from observational studies, published case reports, or postmarketing surveillance, are insufficient to determine whether there is a drug-associated risk for major birth defects or miscarriage.

Gently swirl the vial for 60 seconds. Do not initiate belimumab therapy in patients receiving any therapy for chronic infection.